PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.
- Recall Initiated
- June 26, 2020
- Recall Number
- Z-2805-2020
- Quantity
- 3 units
- Firm Location
- Cohoes, NY
Reason for Recall
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.
Distribution
Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
Lot / Code Info
Lot #: EV123732 Serial #s: L1002, L1005, L1006
Root Cause
Software design
Action Taken
Customers will be e-mailed initial recall notice, followed by written letter. Customers will be directed to ship recalled PreVENT back to PVA as soon as possible. Recalled unit will be shipped back to PVA in the same packaging from replacement unit. Recalled units will be scrapped at PVA.